No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 07332940003821 | INFINITY 80-24 | 900-0496 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
2 | 07332940003937 | GXIV-1-R | 900-0510R | OOI | Real Time Nucleic Acid Amplification System | 2 | Certified Pre-Owned GeneXpert Dx System | |
3 | 07332940003838 | INFINITY 80-16 | 900-0495 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
4 | 07332940003814 | INFINITY 80-32 | 900-0497 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
5 | 07332940003975 | INFINITY 80-72 | 900-0502 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
6 | 07332940003968 | INFINITY 80-80 | 900-0503 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
7 | 07332940006860 | INFINITY 48-48 | 900-0457 | XPERT, GENEXPERT DX SYSTEM | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System |
8 | 07332940006853 | INFINITY 48-40 | 900-0456 | Additional catalog number: 900-0456R | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System |
9 | 07332940006846 | INFINITY 48-32 | 900-0455 | Additional catalog number: 900-0455R | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System |
10 | 07332940006839 | INFINITY 48-24 | 900-0454 | Additional catalog number: 900-0454R | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System |
11 | 07332940004002 | INFINITY 80-48 | 900-0499 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
12 | 07332940004019 | INFINITY 80-40 | 900-0498 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
13 | 07332940003999 | INFINITY 80-56 | 900-0500 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
14 | 07332940003982 | INFINITY 80-64 | 900-0501 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-80 System | |
15 | 07332940002558 | SWAB/A-50 | SWAB/A-50 | Xpert Vaginal/Endocervical Specimen Collection Kit; 50 pack | LIO | Device, Specimen Collection | 1 | Xpert Vaginal/Endocervical Specimen Collection Kit |
16 | 07332940001032 | GXCARBAR-10 | GXCARBAR-10 | Xpert Carba-R test; 10 test kit | POC,PMY | System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, D System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen,System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony | 2 | Xpert Carba-R |
17 | 07332940007669 | GXGBSLBXC | GXGBSLBXC-120 | GBS LB XC | NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | Xpert® |
18 | 07332940007652 | GXGBSLBXC | GXGBSLBXC-10 | GBS LB XC | NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | Xpert® |
19 | 07332940008345 | SWAB/G-50-US | SWAB/G-50-US | Swab Specimen Collection Kit | PQA | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | 2 | Xpert® |
20 | 07332940007072 | XPRSMVP-10 | XPRSMVP-10 | Xpert Xpress MVP | PQA | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | 2 | Xpert® |
21 | 07332940007003 | SWAB/G-50 | SWAB/G-50 | Xpert Swab Specimen Collection Kit; 50 pack | QBD | Microbial Nucleic Acid Storage And Stabilization Device | 2 | Xpert Swab Specimen Collection Kit |
22 | 07332940006457 | SWAB/F-100 | SWAB/F-100 | Nasal Sample Collect Kit for Viruses | JSM | Culture Media, Non-Propagating Transport | 1 | Xpert® |
23 | 07332940002954 | URINE/A-50 | URINE/A-50 | Xpert Urine Specimen Collection Kit; 50 pack | LIO | Device, Specimen Collection | 1 | Xpert Urine Specimen Collection Kit |
24 | 07332940000936 | GXHEMOSIL-10 | GXHEMOSIL-10 | Xpert HemosIL FII & FV kit; 10 test kit | NPQ,NPR | Test, Factor V Leiden Mutations, Genomic Dna Pcr,Test, Factor Ii G20210a Mutatio Test, Factor V Leiden Mutations, Genomic Dna Pcr,Test, Factor Ii G20210a Mutations, Genomic Dna Pcr | 2 | Xpert HemosIL FII & FV |
25 | 07332940006044 | XPRSFLU-10 | XPRSFLU-10 | Xpert Xpress Flu kit; 10 test kit | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Xpert Xpress Flu |
26 | 07332940001001 | GXTV-10 | GXTV-10 | Xpert TV kit; 10 test kit | OUY | Trichomonas Vaginalis Nucleic Acid Amplification Test System | 2 | Xpert TV |
27 | 07332940000974 | GXNOV-10 | GXNOV-10 | Xpert Norovirus kit; 10 test kit | PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 2 | Xpert Norovirus |
28 | 07332940000097 | GXEV-100N-10 | GXEV-100N-10 | Xpert EV kit; 10 test kit | OAI | Assay, Enterovirus Nucleic Acid | 2 | Xpert EV |
29 | 07332940005696 | XPRSFLU/RSV-10 | XPRSFLU/RSV-10 | Xpert Xpress Flu/RSV kit; 10 test kit | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Xpert Xpress Flu/RSV |
30 | 07332940000783 | GXFLU/RSV-10 | GXFLU/RSV-10 | Xpert FLU/RSV XC kit; 10 test kit | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Xpert FLU/RSV XC |
31 | 07332940004347 | INFINITY48-24 | 900-0537 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-48s System | |
32 | 07332940004330 | INFINITY 48-32 | 900-0538 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-48s System | |
33 | 07332940004323 | INFINITY 48-40 | 900-0539 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-48s System | |
34 | 07332940004354 | INFINITY48-16 | 900-0536 | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-48s System | |
35 | 07332940004316 | INFINITY 48-48 | 900-0540 | Additional catalog numbers: 900-0540L, 900-0540R | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert Infinity-48s System |
36 | 07332940002565 | SWAB/B-100 | SWAB/B-100 | Xpert Nasopharyngeal Sample Collection Kit; 100 pack | JSM | Culture Media, Non-Propagating Transport | 1 | Xpert Nasopharyngeal Sample Collection Kit |
37 | 07332940002442 | GXMRSA-120 | GXMRSA-120 | Xpert MRSA kit; 120 test kit | NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 2 | Xpert MRSA |
38 | 07332940001728 | GXMRSA-NXG-120 | GXMRSA-NXG-120 | Xpert MRSA NxG kit: 120 test kit | NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 2 | Xpert MRSA NxG |
39 | 07332940001711 | GXMRSA-NXG-10 | GXMRSA-NXG-10 | Xpert MRSA NxG kit; 10 test kit | NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 2 | Xpert MRSA NxG |
40 | 07332940000196 | GXMRSA-100N-10 | GXMRSA-100N-10 | Xpert MRSA kit; 10 test kit | NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 2 | Xpert MRSA |
41 | 07332940000189 | GXMRSA/SA-SSTI-10 | GXMRSA/SA-SSTI-10 | Xpert MRSA/SA SSTI kit; 10 test kit | NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 2 | Xpert MRSA/SA SSTI |
42 | 07332940000141 | GXMRSA/SA-BC-10 | GXMRSA/SA-BC-10 | Xpert MRSA/SA Blood Culture kit; 10 test kit | NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 2 | Xpert MRSA/SA Blood Culture |
43 | 07332940000059 | GXCDIFFICILE-120 | GXCDIFFICILE-120 | Xpert C. difficile test; 120 test kit | LLH | Reagents, Clostridium Difficile Toxin | 1 | Xpert C. difficile |
44 | 07332940000035 | GXCDIFFICILE-10 | GXCDIFFICILE-10 | Xpert C. difficile test; 10 test kit | LLH | Reagents, Clostridium Difficile Toxin | 1 | Xpert C. difficile |
45 | 07332940006372 | XPRSTREPA-10 | XPRSTREPA-10 | Xpert Xpress Strep A kit; 10 test kit | PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 | Xpert Xpress Strep A |
46 | 07332940002503 | XPRSTREPA-120 | XPRSTREPA-120 | Xpert Xpress Strep A kit; 120 test kit | PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 | Xpert Xpress Strep A |
47 | 07332940000882 | GXGBS-LB-10 | GXGBS-LB-10 | Xpert GBS LB kit; 10 test kit | NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | Xpert GBS LB |
48 | 07332940000806 | GXGBS-LB-120 | GXGBS-LB-120 | Xpert GBS LB kit; 120 test kit | NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | Xpert GBS LB |
49 | 07332940007690 | GX-IV R2 | GX-IV R2 | XPERT, GENEXPERT DX SYSTEM | OOI,NJR | Real Time Nucleic Acid Amplification System,Nucleic Acid Amplification Assay Sys Real Time Nucleic Acid Amplification System,Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | GeneXpert® |
50 | 07332940007195 | GXIV-HUB | 900-0828 | Xpress System | OOI | Real Time Nucleic Acid Amplification System | 2 | GeneXpert® |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04053228033936 | v1 | 9002824 | Additional Catalog Numbers:9002814 QIAstat-Dx Analytical Module9002813 QIAstat-D Additional Catalog Numbers:9002814 QIAstat-Dx Analytical Module9002813 QIAstat-Dx Operational ModuleDI Numbers:QIAstat-Dx Analytical Module DI Number: 04053228033929QIAstat-Dx Operational Module DI Number: 04053228033936 | QIAstat-Dx® Analyzer 1.0 | QIAGEN GMBH |
2 | 04053228033905 | V1 | 691221 | QIAstat-Dx® Respiratory Panel | QIAGEN GMBH | |
3 | 04053228010838 | 1 | 9002035 | Rotor-Gene® Q MDx | QIAGEN GMBH | |
4 | 04053228010746 | 1 | 9001301 | QIAsymphony AS | QIAGEN GMBH | |
5 | 04015630929016 | 05200881001 | 05200881001 | cobas z 480 | ROCHE MOLECULAR SYSTEMS, INC. | |
6 | 03661540951947 | RTK403ING | RTK403ING | The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) base The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. | HSV 1&2 ELITe MGB Assay for CE-IVD | ELITECHGROUP MDX LLC |
7 | 03661540900051 | F2102-000 | F2102-000 | The product «ELITe InGenius® Waste Box» (Catalog code F2102-000) provides dispos The product «ELITe InGenius® Waste Box» (Catalog code F2102-000) provides disposable plastic boxes for collecting tip waste generated during the protocol run for extraction from biological samples, realtime set up in association with the «ELITe InGenius®» a fully automated sample-to-result instrument (Catalog code INT030-K).ELITe InGenius® Waste Box is FDA cleared only for use in association with ELITe InGenius® (Catalog code INT030-K) and HSV1&2 ELITe MGB® Assay. | ELITe InGenius® Waste Box | ELITECHGROUP SPA |
8 | 03661540900044 | INT032CS | The ELITe InGenius® SP 200 Consumable Set (Catalog number INT032CS) provides con The ELITe InGenius® SP 200 Consumable Set (Catalog number INT032CS) provides consumables to be used with ELITe InGenius® SP 200 (Catalog number INT032SP200) extraction cartridge for nucleic acid extraction from biological samples, in association with the ELITe InGenius® instrument (Catalog number INT030-K). ELITe InGenius system, is a fully automated molecular diagnostics system performing extraction, purification, amplification and detection.ELITe InGenius® SP 200 Consumable Set is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay | ELITe InGenius® SP 200 Consumable Set | ELITECHGROUP SPA | |
9 | 03661540900037 | INT035PCR | INT035PCR | The product ELITe InGenius® PCR Cassette (catalog number INT035PCR) provides con The product ELITe InGenius® PCR Cassette (catalog number INT035PCR) provides consumables to be used in association with the ELITe InGenius® instrument (catalog number INT030-K) for Real Time PCR reactions. ELITe InGenius system, is a fully automated molecular diagnostics system performing extraction, purification, amplification and detection.ELITe InGenius® PCR Cassette is FDA cleared only for use in association with HSV1&2 ELITe MGB® Assay. | ELITe InGenius® PCR cassette | ELITECHGROUP SPA |
10 | 03661540900020 | INT032SP200 | INT032SP200 | The product ELITe InGenius® SP 200 extraction cartridge (catalog number INT032SP The product ELITe InGenius® SP 200 extraction cartridge (catalog number INT032SP200) provides reagents used in association with the ELITe InGenius® instrument (catalog number INT030-K) to perform extractions and purification of nucleic acids. ELITe InGenius system, is a fully automated molecular diagnostics system performingextraction, purification, amplification and detection.ELITe InGenius SP 200 is FDA cleared only for use in association with ELITe InGenius® (code INT030-K) instrument and HSV1&2 ELITe MGB® Assay. | ELITe InGenius® SP 200 | ELITECHGROUP SPA |
11 | 03661540900006 | INT030-K | INT030-K | The ELITe InGenius® system is an in vitro diagnostic (IVD) platform that perform The ELITe InGenius® system is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests. The ELITe InGenius system is a fully automated device integrating extraction and purification of nucleic acids from multiple sample types, amplification and detection of the target sequence by real-time Polymerase Chain Reaction (PCR), and result interpretation. ELITe InGenius® is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay | ELITe InGenius® | ELITECHGROUP SPA |
12 | 01812125010067 | AC042 | AC042 | QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel. | Acuitas | OPGEN, INC. |
13 | 00884999049314 | 09N20-012 | 09N20-012 | Alinity m Bottle for Ethanol Use | Alinity m | ABBOTT MOLECULAR INC. |
14 | 00884999048898 | 09N19-012 | 09N19-012 | Alinity m | ABBOTT MOLECULAR INC. | |
15 | 00884999048171 | 09N26-020 | 09N26-020 | Alinity m IRU Waste Container | Alinity m | ABBOTT MOLECULAR INC. |
16 | 00884999048096 | 09N26-019 | 09N26-019 | Alinity m Sample Rack Holder | Alinity m | ABBOTT MOLECULAR INC. |
17 | 00884999048034 | 08N53-002 | 08N53-002 | Alinity m System | Alinity m | ABBOTT MOLECULAR INC. |
18 | 00884999047907 | 09N20-003 | 09N20-003 | Alinity m Diluent Solution Kit | Alinity m | ABBOTT MOLECULAR INC. |
19 | 00884999047884 | 09N50-001 | 09N50-001 | Alinity m Specimen Dilution Kit I | Alinity m | ABBOTT MOLECULAR INC. |
20 | 00884999047877 | 09N20-001 | 09N20-001 | Alinity m Lysis Solution | Alinity m | ABBOTT MOLECULAR INC. |
21 | 00884999047860 | 09N26-010 | 09N26-010 | Alinity m Integrated Reaction Unit (IRU) | Alinity m | ABBOTT MOLECULAR INC. |
22 | 00884999047853 | 09N26-002 | 09N26-002 | Alinity m Pipette Tips, 1000uL | Alinity m | ABBOTT MOLECULAR INC. |
23 | 00884999047846 | 09N26-001 | 09N26-001 | Allinity m Pipette Tips, 50uL | Alinity m | ABBOTT MOLECULAR INC. |
24 | 00884999047716 | 09N20-004 | 09N20-004 | Alinity m Vapor Barrier Solution | Alinity m | ABBOTT MOLECULAR INC. |
25 | 00884999047693 | 09N20-002 | 09N20-002 | Alinity m Ethanol Solution | Alinity m | ABBOTT MOLECULAR INC. |
26 | 00884999047686 | 09N18-001 | 09N18-001 | Alinity m Sample Prep Kit 1 | Alinity m | ABBOTT MOLECULAR INC. |
27 | 00884999047679 | 09N12-001 | 09N12-001 | Alinity m Sample Prep Kit 2 | Alinity m | ABBOTT MOLECULAR INC. |
28 | 00884999047501 | 09N26-004 | 09N26-004 | Alinity m CO-RE Tip Sleeve | Alinity m | ABBOTT MOLECULAR INC. |
29 | 00884999047488 | 09N26-003 | 09N26-003 | Alinity m Pipette Tip Adapters | Alinity m | ABBOTT MOLECULAR INC. |
30 | 00884999047464 | 09N26-016 | 09N26-016 | Alinity m Universal Sample Rack | Alinity m | ABBOTT MOLECULAR INC. |
31 | 00884999047457 | 09N26-015 | 09N26-015 | Alinity m Handheld Barcode Scanner | Alinity m | ABBOTT MOLECULAR INC. |
32 | 00884999047440 | 09N26-014 | 09N26-014 | Alinity m Assay Tray Carrier | Alinity m | ABBOTT MOLECULAR INC. |
33 | 00884999047433 | 09N26-013 | 09N26-013 | Alinity m Waste Bottle | Alinity m | ABBOTT MOLECULAR INC. |
34 | 00884999047426 | 09N26-012 | 09N26-012 | Alinity m Waste Box | Alinity m | ABBOTT MOLECULAR INC. |
35 | 00884999043503 | 08N89-001 | 08N89-001 | m2000rt SYSTEM SOFTWARE Release 8.0 | m2000 | ABBOTT MOLECULAR INC. |
36 | 00884999043497 | 08N88-001 | 08N88-001 | m2000sp SYSTEM SOFTWARE, Release 8.0 | m2000 | ABBOTT MOLECULAR INC. |
37 | 00884999032064 | 9K32-01 | 9K32-01 | Adhesive Cover Applicator | m2000 | ABBOTT MOLECULAR INC. |
38 | 00884999032057 | 9K31-01 | 9K31-01 | Splash Free Support Base | m2000 | ABBOTT MOLECULAR INC. |
39 | 00884999031814 | 9K15-01 | 9K15-01 | m2000rt Instrument System | m2000 | ABBOTT MOLECULAR INC. |
40 | 00884999006577 | 04J71-93 | 04J71-93 | Abbott m2000rt Optical Calibration Kit | m2000 | ABBOTT MOLECULAR INC. |
41 | 00884999006539 | 4J71-75 | 4J71-75 | Optical Adhesive Cover | m2000 | ABBOTT MOLECULAR INC. |
42 | 00884999006522 | 4J71-70 | 4J71-70 | 96-Well Optical Reaction Plate | m2000 | ABBOTT MOLECULAR INC. |
43 | 00875197005950 | 08160104190 | 08160104190 | cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System | ROCHE MOLECULAR SYSTEMS, INC. | |
44 | 00875197005783 | 07460082190 | 07460082190 | cobas CTNG Positive Control Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
45 | 00875197005776 | 07460066190 | 07460066190 | cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems | ROCHE MOLECULAR SYSTEMS, INC. | |
46 | 00875197005738 | 07958021190 | 07958021190 | cobas PCR Media Dual Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
47 | 00875197005721 | 07958030190 | 07958030190 | cobas® PCR Media Uni Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
48 | 00875197005660 | 07402759190 | 07402759190 | cobas Liat Cleaning Tool | ROCHE MOLECULAR SYSTEMS, INC. | |
49 | 00875197005653 | 07402686190 | 07402686190 | cobas® Influenza A/B &RSV Quality Control Kit for use on the cobas® Liat® System | ROCHE MOLECULAR SYSTEMS, INC. | |
50 | 00875197005363 | 2.0 | 07102577190 | cobas® 4800 CT/NG Test v2.0 | ROCHE MOLECULAR SYSTEMS, INC. |